Subathra Ramamoorthy, Veranova, on how forced degradation and trace impurity profiling in potent APIs shape regulator-ready analytical methods.
News|Articles|September 29, 2021
- Pharmaceutical Technology's In the Lab eNewsletter, October 2021
- Volume 16
- Issue 10
USP Publishes General Chapter 1220 of Analytical Procedure Life Cycle
Author(s)Pharmaceutical Technology Editors
USP is publishing the analytics-focused chapter, which considers validation activities, in advance of the official publication.
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The United States Pharmacopeia announced on Sept, 24, 2021, that it is publishing the approved General Chapter <1220> “Analytical Procedure Life Cycle”. The new chapter considers the validation activities that occur throughout the life cycle of an analytical procedure.
This chapter is being published in advance of the official publication posting to allow stakeholders additional time for reading and understanding the new chapter. It will be incorporated into USP–NF 2022, Issue 1 on Nov. 1, 2021 and will become official on May 1, 2022.
The chapter can be accessed
Source:
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